CLINICAL TRIAL TO EVALUATE BLADDER INSTILLATION OF NEOADJUVANT CHEMOTHERAPY TO TRANSURETHRAL RESECTION OF THE BLADDER FOR THE PREVENTION OF RECURRENCE OF NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA
Key facts
- Where
- Badalona, Granada, Madrid és Vitoria, SpanyolországSee the 4 sites
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Germans Trias i PujolBadalona, SpanyolországTaking people
- Hospital Universitario Clínico San CecilioGranada, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario ArabaVitoria, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario La Paz
- Trial code
- EU 2024-512683-53-00
- Record updated
- 2024. április 23.
- Original description
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.Read full original descriptionShow less
RANDOMIZED CLINICAL TRIAL, OPEN, TO EVALUATE THE BLADDER INSTILLATION OF NEOADYUVANT CHEMOTHERAPY TO THE TRANSURETHAL RESECTION OF BLADDER FOR THE PREVENTION OF RECURRENCE OF NONMUSCLE-INVASIVE UROTHELIAL CARCINOMA
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.
Inclusion: Patients of both sexes aged ≥ 18 years; Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT; Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months; Karnofsky scale score > 70%; Patients who agree to participate in the study by signing the informed consent; Patients with tumors <3 cm.
Exclusion: Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT; Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel; Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests; Pregnant patients; Patients in whom it is foreseen that follow-up is not going to be possible for any reason; Patients who for any reason should not be included in the study according to the evaluation of the research team; Patients will be excluded from the clinical trial if, after TURBT, their pathological anatomy report shows a diagnosis other than papillary type IMIBC (CIS only, benign lesions, muscle invasive bladder carcinoma, etc.); Patients with tumors ≥ 3 cm will not be included.